Rescue Progesterone Supplementation During Frozen Embryo Transfer

Fertility Issues Clinical Trial

— P4R  

Official title:

Rescue Progesterone Supplementation in Patients With Low Progesterone on the Day of Embryo Transfer for Artificial Endometrial Preparation Cycles: a Non-inferiority Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05555121
• Other study ID #: IIS-1032
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: Clinique Ovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endometrin is a progesterone supplement prescribed during in vitro fertilization (IVF) for preparation for embryo transfer. The usual dose of Endometrin is 100 mg two to three times per day in the form of an effervescent tablet to be inserted vaginally.

The purpose of this research project is to evaluate the dose response of the Endometrin when determined based on the blood level of progesterone on the day of the FET. According to the literature, a predefined level of progesterone in the blood should be reached in order to have favorable conditions for pregnancy. The hypothesis being that a woman with low progesterone levels would benefit from a dose of Endometrin of 600 mg (200 mg 3x/day) to decrease the risk of miscarriage and improve the chances of pregnancy. Women with adequate progesterone levels according to the literature, would continue with the standard dose of progesterone prescribed at clinique ovo which is 300 mg (100 mg 3x/day).

PIBF (Progesterone Induced Blocking Factor) levels, a protein found in the blood that could also predict pregnancy outcomes in women using IVF will also be looked at.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• Women 18-42 years of age

• Normal uterine cavity (according to treating physician)

• FET substituted cycle prescribed

• First or second cycle of FET

• Adequate endometrial pattern (triple layer) and thickness (>7 mm) after adequate standard endometrial preparation in artificial cycle

Exclusion Criteria:

• Any uterine abnormalities confirmed by treating physician making participant unable to proceed with FET

• Patients with personalized FET according to the endometrial receptivity assay tests

• Previous allergic reactions to progesterone or any of the ingredients of Endometrin

• Severe hepatic dysfunction or disease

• Known or suspected breast cancer or genital tract cancer

• Known active arterial or venous thromboembolism or severe thrombophlebitis or cerebro-vascular disease, or a history of these events

• Diagnosed porphyria

• Undiagnosed abnormal vaginal bleeding

• Known missed abortion or ectopic pregnancy

• Recurrent pregnancy loss excluding biochemical pregnancies

• Hypersensitivity to Acetylsalicylic acid (ASA), salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, antipyretics or other ingredients in the product or component of the container

• Acute gastrointestinal ulcer, history of gastrointestinal ulcers and hemorrhagic diathesis

• Active or severe renal disease, or congestive heart failure

• History of asthma induced by salicylates or other NSAIDs

• Use of methotrexate at doses of 15mg/week or more

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Related Conditions & MeSH terms

• Embryo Implantation
• Fertility Issues
• Frozen Embryo Transfer
• Infertility

Intervention

Drug:
• Progesterone Effervescent Vaginal Tablet
On the day of Frozen Embryo Transfer (FET), women will have a blood test to determine progesterone levels. Depending on the result of progesterone level, the participant will be assigned to either the Endometrin 100 mg TID dose or the Endometrin 200 mg TID dose

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Clinique Ovo	Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood test to evaluate the prevalence of PIBF	Progesterone Inducing Blocking Factor (PIBF) has been found to to have an important part in creating a welcoming environment for the embryo	Before embryo transfer and 10 days after embryo transfer
Primary	Evaluate the ongoing pregnancy rate	Viability ultrasound	6 to 8 weeks after Frozen Embryo Transfer
Secondary	Evaluate the miscarriage rate	Viability ultrasound	6 to 8 weeks after Frozen Embryo Transfer
Secondary	Evaluate progesterone levels	Progesterone levels will be tested at two different times	Before embryo transfer and 10 days after embryo transfer
Secondary	Evaluate the rate of biochemical pregnancy	Serum pregnancy test to measure Beta Human Chorionic Gonadotropin (BhCG) levels	10 days after frozen embryo transfer